Remote respiratory therapy device management

ABSTRACT

A system and method for updating patient devices is disclosed. The patient devices ( 720, 730, 740 ) may include respiratory therapy devices ( 4000 ) that operate in accordance with instruction sets ( 726 ), such as software or firmware. A server ( 710 ) may maintain a database of configuration data ( 718 ) indicating the versions of the software and firmware that is currently installed on the patient devices ( 720, 730, 740 ). The server ( 710 ) may also transmit updated instructions ( 716 ) from over a network ( 4282 ), including a wireless network. Particular patient devices ( 720, 730, 740 ) may be selected for updating based on the configuration data ( 718 ). Upon performing an update a patient device ( 720, 730, 740 ) may transmit configuration data ( 728 ) to the server ( 710 ).

CROSS-REFERENCES TO RELATED APPLICATIONS

The present application claims priority to Australian ProvisionalApplication No. 2014901999, filed on May 27, 2014, the disclosure ofwhich is incorporated herein by reference.

1 BACKGROUND

1.1 (1) Field of the Technology

The present technology relates to one or more of the detection,diagnosis, treatment, prevention and amelioration of respiratory-relateddisorders. In particular, the present technology relates to medicaldevices or apparatus, their use, and updating the same.

1.2 (2) Description of the Related Art

1.2.1 Human Respiratory System and its Disorders

The respiratory system of the body facilitates gas exchange. The noseand mouth form the entrance to the airways of a patient.

The airways include a series of branching tubes, which become narrower,shorter and more numerous as they penetrate deeper into the lung. Theprime function of the lung is gas exchange, allowing oxygen to move fromthe air into the venous blood and carbon dioxide to move out. Thetrachea divides into right and left main bronchi, which further divideeventually into terminal bronchioles. The bronchi make up the conductingairways, and do not take part in gas exchange. Further divisions of theairways lead to the respiratory bronchioles, and eventually to thealveoli. The alveolated region of the lung is where the gas exchangetakes place, and is referred to as the respiratory zone. See“Respiratory Physiology”, by John B. West, Lippincott Williams &Wilkins, 9th edition published 2011.

A range of respiratory disorders exist. Some examples of respiratorydisorders include: Obstructive Sleep Apnea (OSA), Cheyne StokesRespiration (CSR), Obesity Hyperventilation Syndrome (OHS), ChronicObstructive Pulmonary Disease (COPD), Neuromuscular Disease (NMD) orchest wall disorders.

Otherwise healthy individuals may take advantage of systems and devicesto prevent respiratory disorders from arising.

1.2.2 Therapy

Nasal Continuous Positive Airway Pressure (CPAP) therapy has been usedto treat Obstructive Sleep Apnea (OSA). The hypothesis is thatcontinuous positive airway pressure acts as a pneumatic splint and mayprevent upper airway occlusion by pushing the soft palate and tongueforward and away from the posterior oropharyngeal wall.

Non-invasive ventilation (NIV) provides ventilator support to a patientthrough the upper airways to assist the patient in taking a full breathand/or maintain adequate oxygen levels in the body by doing some or allof the work of breathing. The ventilator support is provided via apatient interface. NIV has been used to treat CSR, OHS, COPD, MD andChest Wall disorders.

Invasive ventilation (IV) provides ventilatory support to patients thatare no longer able to effectively breathe themselves and is providedusing a tracheostomy tube.

Ventilators may control the timing and pressure of breaths pumped intothe patient and monitor the breaths taken by the patient. The methods ofcontrol and monitoring patients typically include volume-cycled andpressure-cycled methods. The volume-cycled methods may include amongothers, Pressure-Regulated Volume Control (PRVC), Volume Ventilation(VV), and Volume Controlled Continuous Mandatory Ventilation (VC-CMV)techniques. The pressure-cycled methods may involve, among others,Assist Control (AC), Synchronized Intermittent Mandatory Ventilation(SIMV), Controlled Mechanical Ventilation (CMV), Pressure SupportVentilation (PSV), Continuous Positive Airway Pressure (CPAP), orPositive End Expiratory Pressure (PEEP) techniques.

1.2.3 Systems

A treatment system may comprise a Respiratory Pressure Therapy Device(RPT device), an air circuit, a humidifier, a patient interface, anddata management.

1.2.4 Patient Interface

A patient interface may be used to interface respiratory equipment toits user, for example by providing a flow of breathable gas. The flow ofbreathable gas may be provided via a mask to the nose and/or mouth, atube to the mouth or a tracheostomy tube to the trachea of the user.Depending upon the therapy to be applied, the patient interface may forma seal, e.g. with a face region of the patient, to facilitate thedelivery of gas at a pressure at sufficient variance with ambientpressure to effect therapy, e.g. a positive pressure of about 10 cm H2O.For other forms of therapy, such as the delivery of oxygen, the patientinterface may not include a seal sufficient to facilitate delivery tothe airways of a supply of gas at a positive pressure of about 10 cmH2O.

The design of a patient interface presents a number of challenges. Theface has a complex three-dimensional shape. The size and shape of nosesvaries considerably between individuals. Since the head includes bone,cartilage and soft tissue, different regions of the face responddifferently to mechanical forces. The jaw or mandible may move relativeto other bones of the skull. The whole head may move during the courseof a period of respiratory therapy.

As a consequence of these challenges, some masks suffer from being oneor more of obtrusive, aesthetically undesirable, costly, poorly fitting,difficult to use and uncomfortable especially when worn for long periodsof time or when a patient is unfamiliar with a system. For example,masks designed solely for aviators, mask designed as part of personalprotection equipment (e.g. filter masks), SCUBA masks or for theadministration of anaesthetics may be tolerable for their originalapplication, but nevertheless be undesirably uncomfortable to be wornfor extended periods of time, e.g. several hours. This is even more soif the mask is to be worn during sleep.

Nasal CPAP therapy is highly effective to treat certain respiratorydisorders, provided patients comply with therapy. If a mask isuncomfortable, or difficult to use a patient may not comply withtherapy. Since it is often recommended that a patient regularly washtheir mask, if a mask is difficult to clean (e.g. difficult to assembleor disassemble), patients may not clean their mask and this may impacton patient compliance.

While a mask for other applications (e.g. aviators) may not be suitablefor use in treating sleep disordered breathing, a mask designed for usein treating sleep disordered breathing may be suitable for otherapplications.

For these reasons, masks for delivery of nasal CPAP during sleep form adistinct field.

1.2.4.1 Seal-Forming Portion

Patient interfaces may include a seal-forming portion. Since it is indirect contact with the patient's face, the shape and configuration ofthe seal-forming portion can have a direct impact the effectiveness andcomfort of the patient interface.

A patient interface may be partly characterised according to the designintent of where the seal-forming portion is to engage with the face inuse. In one form of patient interface, a seal-forming portion maycomprise two sub-portions to engage with respective left and rightnares. In one form of patient interface, a seal-forming portion maycomprise a single element that surrounds both nares in use. Such singleelement may be designed to for example overlay an upper lip region and anasal bridge region of a face. In one form of patient interface aseal-forming portion may comprise an element that surrounds a mouthregion in use, e.g. by forming a seal on a lower lip region of a face.In one form of patient interface, a seal-forming portion may comprise asingle element that surrounds both nares and a mouth region in use.These different types of patient interfaces may be known by a variety ofnames by their manufacturer including nasal masks, full-face masks,nasal pillows, nasal puffs and oro-nasal masks.

A seal-forming portion that may be effective in one region of apatient's face may be in appropriate in another region, e.g. because ofthe different shape, structure, variability and sensitivity regions ofthe patient's face. For example, a seal on swimming goggles thatoverlays a patient's forehead may not be appropriate to use on apatient's nose.

Certain seal-forming portions may be designed for mass manufacture suchthat one design fit and be comfortable and effective for a wide range ofdifferent face shapes and sizes. To the extent to which there is amismatch between the shape of the patient's face, and the seal-formingportion of the mass-manufactured patient interface, one or both mustadapt in order for a seal to form.

One type of seal-forming portion extends around the periphery of thepatient interface, and is intended to seal against the user's face whenforce is applied to the patient interface with the seal-forming portionin confronting engagement with the user's face. The seal-forming portionmay include an air or fluid filled cushion, or a moulded or formedsurface of a resilient seal element made of an elastomer such as arubber. With this type of seal-forming portion, if the fit is notadequate, there will be gaps between the seal-forming portion and theface, and additional force will be required to force the patientinterface against the face in order to achieve a seal.

Another type of seal-forming portion incorporates a flap seal of thinmaterial so positioned about the periphery of the mask so as to providea self-sealing action against the face of the user when positivepressure is applied within the mask. Like the previous style of sealforming portion, if the match between the face and the mask is not good,additional force may be required to affect a seal, or the mask may leak.Furthermore, if the shape of the seal-forming portion does not matchthat of the patient, it may crease or buckle in use, giving rise toleaks.

Another type of seal-forming portion may comprise a friction-fitelement, e.g. for insertion into a naris.

Another form of seal-forming portion may use adhesive to affect a seal.Some patients may find it inconvenient to constantly apply and remove anadhesive to their face.

A range of patient interface seal-forming portion technologies aredisclosed in the following patent applications, assigned to ResMedLimited: WO 1998/004,310; WO 2006/074,513; WO 2010/135,785.

One form of nasal pillow is found in the Adam Circuit manufactured byPuritan Bennett. Another nasal pillow, or nasal puff is the subject ofU.S. Pat. No. 4,782,832 (Trimble et al.), assigned to Puritan-BennettCorporation.

ResMed Limited has manufactured the following products that incorporatenasal pillows: SWIFT nasal pillows mask, SWIFT II nasal pillows mask,SWIFT LT nasal pillows mask, SWIFT FX nasal pillows mask and LIBERTYfull-face mask. The following patent applications, assigned to ResMedLimited, describe nasal pillows masks: International Patent ApplicationWO2004/073,778 (describing amongst other things aspects of ResMed SWIFTnasal pillows), US Patent Application 2009/0044808 (describing amongstother things aspects of ResMed SWIFT LT nasal pillows); InternationalPatent Applications WO 2005/063,328 and WO 2006/130,903 (describingamongst other things aspects of ResMed LIBERTY full-face mask);International Patent Application WO 2009/052,560 (describing amongstother things aspects of ResMed SWIFT FX nasal pillows).

1.2.4.2 Positioning and Stabilising

A seal-forming portion of a patient interface used for positive airpressure therapy is subject to the corresponding force of the airpressure to disrupt a seal. Thus a variety of techniques have been usedto position the seal-forming portion, and to maintain it in sealingrelation with the appropriate portion of the face.

One technique is the use of adhesives. See for example US Patentpublication US 2010/0000534.

Another technique is the use of one or more straps and stabilisingharnesses. Many such harnesses suffer from being one or more ofill-fitting, bulky, uncomfortable and awkward to use.

1.2.5 Respiratory Pressure Therapy (RPT) Device

One known RPT device used for treating sleep disordered breathing is theS9 Sleep Therapy System, manufactured by ResMed. Another example of anRPT device is a ventilator. Ventilators such as the ResMed Stellar™Series of Adult and Paediatric Ventilators may provide support forinvasive and non-invasive non-dependent ventilation for a range ofpatients for treating a number of conditions such as but not limited toNMD, OHS and COPD. RPT devices have also been known as flow generators.

The ResMed Elisée™ 150 ventilator and ResMed VS III™ ventilator mayprovide support for invasive and non-invasive dependent ventilationsuitable for adult or paediatric patients for treating a number ofconditions. These ventilators provide volumetric and barometricventilation modes with a single or double limb circuit.

RPT devices typically comprise a pressure generator, such as amotor-driven blower or a compressed gas reservoir, and are configured tosupply a flow of air to the airway of a patient. In some cases, the flowof air may be supplied to the airway of the patient at positivepressure. The outlet of the RPT device is connected via an air circuitto a patient interface such as those described above.

RPT devices typically also include an inlet filter, various sensors anda microprocessor-based controller. A blower may include aservo-controlled motor, a volute and an impeller. In some cases a brakefor the motor may be implemented to more rapidly reduce the speed of theblower so as to overcome the inertia of the motor and impeller. Thebraking can permit the blower to more rapidly achieve a lower pressurecondition in time for synchronization with expiration despite theinertia. In some cases the pressure generator may also include a valvecapable of discharging generated air to atmosphere as a means foraltering the pressure delivered to the patient as an alternative tomotor speed control. The sensors measure, amongst other things, motorspeed, mass flow rate and outlet pressure, such as with a pressuretransducer or the like. The controller may include data storage capacitywith or without integrated data retrieval and display functions.

Table of noise output levels of prior devices (one specimen only,measured using test method specified in ISO3744 in CPAP mode at 10 cmH₂O).

A-weighted sound power Year Device name level dB(A) (approx.) C-SeriesTango 31.9 2007 C-Series Tango with Humidifier 33.1 2007 S8 Escape II30.5 2005 S8 Escape II with H4i Humidifier 31.1 2005 S9 AutoSet 26.52010 S9 AutoSet with H5i Humidifier 28.6 2010

1.2.6 Humidifier

Delivery of a flow of breathable gas without humidification may causedrying of airways. Medical humidifiers are used to increase humidityand/or temperature of the flow of breathable gas in relation to ambientair when required, typically where the patient may be asleep or resting(e.g. at a hospital). As a result, a medical humidifier is preferablysmall for bedside placement, and it is preferably configured to onlyhumidify and/or heat the flow of breathable gas delivered to the patientwithout humidifying and/or heating the patient's surroundings.Room-based systems (e.g. a sauna, an air conditioner, an evaporativecooler), for example, may also humidify air that is breathed in by thepatient, however they would also humidify and/or heat the entire room,which may cause discomfort to the occupants.

The use of a humidifier with a flow generator or RPT device and thepatient interface produces humidified gas that minimizes drying of thenasal mucosa and increases patient airway comfort. In addition, incooler climates warm air applied generally to the face area in and aboutthe patient interface is more comfortable than cold air.

Respiratory humidifiers are available in many forms and may be astandalone device that is coupled to a respiratory apparatus via an aircircuit, is integrated with or configured to be coupled to the relevantrespiratory apparatus. While known passive humidifiers can provide somerelief, generally a heated humidifier may be used to provide sufficienthumidity and temperature to the air so that the patient will becomfortable. Humidifiers typically comprise a water reservoir or tubhaving a capacity of several hundred milliliters (ml), a heating elementfor heating the water in the reservoir, a control to enable the level ofhumidification to be varied, a gas inlet to receive gas from the flowgenerator or RPT device, and a gas outlet adapted to be connected to anair circuit that delivers the humidified gas to the patient interface.

Heated passover humidification is one common form of humidification usedwith a RPT device. In such humidifiers the heating element may beincorporated in a heater plate which sits under, and is in thermalcontact with, the water tub. Thus, heat is transferred from the heaterplate to the water reservoir primarily by conduction. The air flow fromthe RPT device passes over the heated water in the water tub resultingin water vapour being taken up by the air flow. The ResMed H4i™ and H5i™Humidifiers are examples of such heated passover humidifiers that areused in combination with ResMed S8 and S9 CPAP devices respectively.

Other humidifiers may also be used such as a bubble or diffuserhumidifier, a jet humidifier or a wicking humidifier. In a bubble ordiffuser humidifier the air is conducted below the surface of the waterand allowed to bubble back to the top. A jet humidifier produces anaerosol of water and baffles or filters may be used so that theparticles are either removed or evaporated before leaving thehumidifier. A wicking humidifier uses a water absorbing material, suchas sponge or paper, to absorb water by capillary action. The waterabsorbing material is placed within or adjacent at least a portion ofthe air flow path to allow evaporation of the water in the absorbingmaterial to be taken up into the air flow.

An alternative form of humidification is provided by the ResMedHumiCare™ D900 humidifier that uses a CounterStream™ technology thatdirects the air flow over a large surface area in a first directionwhilst supplying heated water to the large surface area in a secondopposite direction. The ResMed HumiCare™ D900 humidifier may be usedwith a range of invasive and non-invasive ventilators.

2 BRIEF SUMMARY OF THE TECHNOLOGY

Aspects of the disclosure provide a computer implemented method forupdating a patient device over a network. The method may includeaccessing configuration data relating to a plurality of patient devices,wherein the plurality of patient devices each implements a set ofinstructions. The method may also include identifying one or morepatient devices, from the plurality of patient devices, havingconfiguration data that meets one or more criteria and selecting, in thecase where more than one updates are provided, an instruction update tobe provided to the one or more patient devices, wherein theconfiguration data indicates that the instruction update is notcurrently installed on the one or more patient devices. The method mayalso include transmitting the instruction update to the one or morepatient devices, as well as determining whether each of the one or morepatient devices successfully installed the instruction update. Inaddition the configuration data may be updated for each of the one ormore patient devices that successfully installed the instruction update.

In another aspect, the instruction update may include at least one ofthe following: data specifying a location of an instruction update file;instructions as to which component of the device should the update beapplied to; schedule time for performing the update for each device;instructions on whether or not to request confirmation that the updateshould be applied; instructions for the update not be applied untilpatient treatment is stopped, if applicable; data structure andfunctionality enabling cancelling upgrades that have not yet occurred;batch capability to request bulk upgrades in a single operation; and anability to check a status of these upgrades in a single operationindicating the status of the upgrades.

Selecting the one or more criteria and the instruction update may bebased on received one or more transmissions from a remote computingdevice, e.g. the computer of a clinician or service personnel. Inaddition, the step of selecting the instruction update may be based onreceiving input from a user of the remote computing device indicatingthe instruction update, from a plurality of instruction updates.Transmitting the instruction update may further include transmittingverification data, wherein the verification data is used by the patientdevice to verify that the received instruction update is complete. Inthis case the expression that the update is “complete” is also meant toindicate that the update is without corruption or alteration in any way.The instruction update may be retransmitted to each device for which itis determined that the instruction update was not successfullyinstalled.

In accordance with yet another aspect, an indication from each of theone or more patient devices indicates that the instruction set wassuccessfully installed, and a message may be transmitted to a computingdevice, wherein the message identifies successful installation of theinstruction update for the one or more patient devices. Theconfiguration data may include at least one of a) a serial number, b) aversion of the set of instructions that is currently installed on thepatient device, c) a hardware version, d) a region in which the patientdevice is being used, and e) a record of the instruction updates thathave previously been successfully or unsuccessfully applied to thepatient device.

In accordance with still another aspect, the plurality of patientdevices may be respiratory pressure therapy devices. The configurationdata may include at least one of a) a serial number, b) a version of theset of instructions that is currently installed on the patient device,and c) a hardware version. In addition, the instruction update mayinclude a first portion and a second portion, herein a first componentof the patient device operates in accordance with the first portion ofthe instruction update and a second component operates in accordancewith the second portion of the instruction update.

In another aspect, a method for updating a device for providing medicalmay include accessing a first set of instructions for operation of apatient device; performing a first set of operations in accordance withthe first instruction set; receiving update data from a remote computingdevice over a network; updating the first set of instructions inaccordance with the update data so as to generate an updated set ofinstructions; transmitting confirmation to the remote computing devicethat an update of the first set of instructions has occurred; andperforming a second set of operations in accordance with the updated setof instructions.

The method may also include receiving verification data, and furthercomprising determination of whether the received update data iscomplete. If the received update data is determined to be incomplete,the patient device may transmit an error notification to the remotecomputing device and receive a second transmission of update data.

3 BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

The present technology is illustrated by way of example, and not by wayof limitation, in the figures of the accompanying drawings, in whichlike reference numerals refer to similar elements including:

3.1 Treatment Systems

FIG. 1a shows a system in accordance with the present technology. Apatient 1000 wearing a patient interface 3000, in the form of nasalpillows, receives a supply of air at positive pressure from a RPT device4000. Air from the RPT device is humidified in a humidifier 5000, andpasses along an air circuit 4170 to the patient 1000.

FIG. 1b shows a system including a patient 1000 wearing a patientinterface 3000, in the form of a nasal mask, receives a supply of air atpositive pressure from a RPT device 4000. Air from the RPT device ishumidified in a humidifier 5000, and passes along an air circuit 4170 tothe patient 1000.

FIG. 1c shows a system including a patient 1000 wearing a patientinterface 3000, in the form of a full-face mask, receives a supply ofair at positive pressure from a RPT device. Air from the RPT device ishumidified in a humidifier 5000, and passes along an air circuit 4170 tothe patient 1000.

3.2 Therapy 3.2.1 Respiratory System

FIG. 2a shows an overview of a human respiratory system including thenasal and oral cavities, the larynx, vocal folds, oesophagus, trachea,bronchus, lung, alveolar sacs, heart and diaphragm.

FIG. 2b shows a view of a human upper airway including the nasal cavity,nasal bone, lateral nasal cartilage, greater alar cartilage, nostril,lip superior, lip inferior, larynx, hard palate, soft palate,oropharynx, tongue, epiglottis, vocal folds, oesophagus and trachea.

3.2.2 Facial Anatomy

FIG. 2c is a front view of a face with several features of surfaceanatomy identified including the lip superior, upper vermillion, lowervermillion, lip inferior, mouth width, endocanthion, a nasal ala,nasolabial sulcus and cheilion.

3.3 Patient Interface

FIG. 3a shows an example of a patient interface known in the prior art.

3.4 Respiratory Pressure Therapy (RPT) Device

FIG. 4a shows a RPT device in accordance with one form of the presenttechnology.

FIG. 4b shows a schematic diagram of the pneumatic circuit of a RPTdevice in accordance with one form of the present technology. Thedirections of upstream and downstream are indicated.

FIG. 4c shows a schematic diagram of the electrical components of a RPTdevice in accordance with one aspect of the present technology.

3.5 Humidifier

FIG. 5a shows a humidifier in accordance with one aspect of the presenttechnology.

3.6 Breathing Waveforms

FIG. 6a shows a model typical breath waveform of a person whilesleeping, the horizontal axis is time, and the vertical axis isrespiratory flow. While the parameter values may vary, a typical breathmay have the following approximate values: tidal volume, Vt, 0.5 L,inhalation time, Ti, 1.6 s, peak inspiratory flow, Qpeak, 0.4 L/s,exhalation time, Te, 2.4 s, peak expiratory flow, Qpeak, −0.5 L/s. Thetotal duration of the breath, Ttot, is about 4 s. The person typicallybreathes at a rate of about 15 breaths per minute (BPM), withVentilation, Vent, about 7.5 L/s. A typical duty cycle, the ratio of Tito Ttot is about 40%.

3.7 Data Management System

FIG. 7 shows an example communications system 700 that may be used inthe collection and transmission of patient data. Each patient device720, 730, and 740 may comprise an RPT 4000, humidifier 5000, and patientinterface 3000.

FIG. 8 shows flow diagram 800 of operations that may be performed bypatient devices disclosed herein in connection with updating instructionsets that are implemented by the patient device.

FIG. 9 shows flow diagram 900 operations that may be performed bycomputing devices, such as servers, disclosed herein.

4 DETAILED DESCRIPTION OF EXAMPLES OF THE TECHNOLOGY

Before the present technology is described in further detail, it is tobe understood that the technology is not limited to the particularexamples described herein, which may vary. It is also to be understoodthat the terminology used in this disclosure is for the purpose ofdescribing only the particular examples discussed herein, and is notintended to be limiting.

4.1 TREATMENT SYSTEMS

In one form, the present technology comprises apparatus for treating arespiratory disorder. The apparatus may comprise a flow generator orblower for supplying pressurised respiratory gas, such as air, to thepatient 1000 via an air delivery tube leading to a patient interface3000.

4.2 THERAPY

In one form, the present technology comprises a method for treating arespiratory disorder comprising the step of applying positive pressureto the entrance of the airways of a patient 1000.

4.2.1 Nasal CPAP for OSA

In one form, the present technology comprises a method of treatingObstructive Sleep Apnea in a patient by applying nasal continuouspositive airway pressure to the patient.

4.3 PATIENT INTERFACE 3000

A non-invasive patient interface 3000 in accordance with one aspect ofthe present technology comprises the following functional aspects: aseal-forming structure 3100, a plenum chamber 3200, a positioning andstabilising structure 3300, a vent 3400 and a connection port 3600 forconnection to air circuit 4170. In some forms a functional aspect may beprovided by one or more physical components. In some forms, one physicalcomponent may provide one or more functional aspects. In use theseal-forming structure 3100 is arranged to surround an entrance to theairways of the patient so as to facilitate the supply of air at positivepressure to the airways.

4.3.1 Seal-Forming Structure 3100

In one form of the present technology, a seal-forming structure 3100provides a sealing-forming surface, and may additionally provide acushioning function.

A seal-forming structure 3100 in accordance with the present technologymay be constructed from a soft, flexible, resilient material such assilicone.

In one form, the seal-forming structure 3100 comprises a sealing flangeand a support flange. Preferably the sealing flange comprises arelatively thin member with a thickness of less than about 1 mm, forexample about 0.25 mm to about 0.45 mm, that extends around theperimeter 3210 of the plenum chamber 3200. Support flange may berelatively thicker than the sealing flange. The support flange isdisposed between the sealing flange and the marginal edge of the plenumchamber 3200, and extends at least part of the way around the perimeter3210. The support flange is or includes a spring-like element andfunctions to support the sealing flange from buckling in use. In use thesealing flange can readily respond to system pressure in the plenumchamber 3200 acting on its underside to urge it into tight sealingengagement with the face.

In one form the seal-forming portion of the non-invasive patientinterface 3000 comprises a pair of nasal puffs, or nasal pillows, eachnasal puff or nasal pillow being constructed and arranged to form a sealwith a respective naris of the nose of a patient.

Nasal pillows in accordance with an aspect of the present technologyinclude: a frusto-cone, at least a portion of which forms a seal on anunderside of the patient's nose; a stalk, a flexible region on theunderside of the cone and connecting the cone to the stalk. In addition,the structure to which the nasal pillow of the present technology isconnected includes a flexible region adjacent the base of the stalk. Theflexible regions can act in concert to facilitate a universal jointstructure that is accommodating of relative movement—both displacementand angular—of the frusto-cone and the structure to which the nasalpillow is connected. For example, the frusto-cone may be axiallydisplaced towards the structure to which the stalk is connected.

In one form the non-invasive patient interface 3000 comprises aseal-forming portion that forms a seal in use on an upper lip region(that is, the lip superior) of the patient's face.

In one form the non-invasive patient interface 3000 comprises aseal-forming portion that forms a seal in use on a chin-region of thepatient's face.

4.3.2 Plenum Chamber 3200

Preferably the plenum chamber 3200 has a perimeter 3210 that is shapedto be complementary to the surface contour of the face of an averageperson in the region where a seal will form in use. In use, a marginaledge of the plenum chamber 3200 is positioned in close proximity to anadjacent surface of the face. Actual contact with the face is providedby the seal-forming structure 3100. Preferably the seal-formingstructure 3100 extends in use about the entire perimeter 3210 of theplenum chamber 3200.

In one form, the plenum chamber 3200 may surround and/or be in fluidcommunication with the nares of the patient where the plenum chamber3200 is a part of a nasal mask (e.g. shown in FIG. 1b ). In anotherform, the plenum chamber 3200 may surround and/or be in fluidcommunication with the nares and the mouth of the patient where theplenum chamber 3200 is a part of a full-face mask (e.g., shown in FIG.1c ). In yet another form, the plenum chamber 3200 may engage and/or bein fluid communication with one or more of the nares of the patientwhere the plenum chamber 3200 is a part of nasal pillows (e.g., shown inFIG. 29).

4.3.3 Positioning and Stabilising Structure 3300

Preferably the seal-forming structure 3100 of the patient interface 3000of the present technology is held in sealing position in use by thepositioning and stabilising structure 3300.

4.4 RPT DEVICE 4000

An example RPT device 4000 that may be suitable for implementing aspectsof the present technology may include mechanical and pneumaticcomponents 4100, electrical components 4200 and may be programmed toexecute one or more of the control methodologies or algorithms describedthroughout this specification. The RPT device may have an externalhousing 4010, preferably formed in two parts, an upper portion 4012 ofthe external housing 4010, and a lower portion 4014 of the externalhousing 4010. In alternative forms, the external housing 4010 mayinclude one or more panel(s) 4015. Preferably the RPT device 4000comprises a chassis 4016 that supports one or more internal componentsof the RPT device 4000. In one form a pneumatic block 4020 is supportedby, or formed as part of the chassis 4016. The RPT device 4000 mayinclude a handle 4018.

The pneumatic path of the RPT device 4000 preferably comprises an inletair filter 4112, an inlet muffler 4122, a controllable pressure device4140 capable of supplying air at positive pressure (preferably a blower4142), and an outlet muffler 4124. One or more pressure transducers 4272and flow sensors 4274 are included in the pneumatic path.

The preferred pneumatic block 4020 comprises a portion of the pneumaticpath that is located within the external housing 4010.

The RPT device 4000 preferably has an electrical power supply 4210, oneor more input devices 4220, a central controller 4230, a therapy devicecontroller 4240 and/or any of the controllers previously described, apressure device 4140, one or more protection circuits 4250, memory 4260,transducers 4270, data communication interface 4280 and one or moreoutput devices 4290. Electrical components 4200 may be mounted on asingle Printed Circuit Board Assembly (PCBA) 4202. In an alternativeform, the RPT device 4000 may include more than one PCBA 4202.

The central controller 4230 of the RPT device 4000, which may includeone or more processors, can be programmed to execute one or morealgorithm modules, preferably including a pre-processing module, atherapy engine module, a pressure control module, and further preferablya fault condition module. It may further include a vent control modulethat may be configured with one or more of the vent controlmethodologies described throughout this specification.

4.4.1 RPT Device Mechanical & Pneumatic Components 4100 4.4.1.1 AirFilter(s) 4110

A RPT device in accordance with one form of the present technology mayinclude an air filter 4110, or a plurality of air filters 4110.

In one form, an inlet air filter 4112 is located at the beginning of thepneumatic path upstream of a blower 4142. See FIG. 4 b.

In one form, an outlet air filter 4114, for example an antibacterialfilter, is located between an outlet of the pneumatic block 4020 and apatient interface 3000. See FIG. 4 b.

4.4.1.2 Muffler(s) 4120

In one form of the present technology, an inlet muffler 4122 is locatedin the pneumatic path upstream of a blower 4142. See FIG. 4 b.

In one form of the present technology, an outlet muffler 4124 is locatedin the pneumatic path between the blower 4142 and a patient interface3000. See FIG. 4 b.

4.4.1.3 Pressure Device 4140

In a preferred form of the present technology, a pressure device 4140for producing a flow of air at positive pressure is a controllableblower 4142. For example the blower may include a brushless DC motor4144 with one or more impellers housed in a volute. The blower may bepreferably capable of delivering a supply of air, for example about 120litres/minute, at a positive pressure in a range from about 4 cm H₂O toabout 20 cm H₂O, or in other forms up to about 30 cm H₂O.

The pressure device 4140 is under the control of the therapy devicecontroller 4240.

4.4.1.4 Transducer(s) 4270

In one form of the present technology, one or more transducers 4270 arelocated upstream of the pressure device 4140. The one or moretransducers 4270 are constructed and arranged to measure properties ofthe air at that point in the pneumatic path.

In one form of the present technology, one or more transducers 4270 arelocated downstream of the pressure device 4140, and upstream of the aircircuit 4170. The one or more transducers 4270 are constructed andarranged to measure properties of the air at that point in the pneumaticpath.

In one form of the present technology, one or more transducers 4270 arelocated proximate to the patient interface 3000.

4.4.1.5 Anti-Spill Back Valve 4160

In one form of the present technology, an anti-spill back valve islocated between the humidifier 5000 and the pneumatic block 4020. Theanti-spill back valve is constructed and arranged to reduce the riskthat water will flow upstream from the humidifier 5000, for example tothe motor 4144.

4.4.1.6 Air Circuit 4170

An air circuit 4170 in accordance with an aspect of the presenttechnology is constructed and arranged to allow a flow of air orbreathable gasses between the pneumatic block 4020 and the patientinterface 3000.

4.4.1.7 Oxygen Delivery

In one form of the present technology, supplemental oxygen 4180 isdelivered to a point in the pneumatic path.

In one form of the present technology, supplemental oxygen 4180 isdelivered upstream of the pneumatic block 4020.

In one form of the present technology, supplemental oxygen 4180 isdelivered to the air circuit 4170.

In one form of the present technology, supplemental oxygen 4180 isdelivered to the patient interface 3000.

4.4.2 RPT Device Electrical Components 4200 4.4.2.1 Power Supply 4210

In one form of the present technology power supply 4210 is internal ofthe external housing 4010 of the RPT device 4000. In another form of thepresent technology, power supply 4210 is external of the externalhousing 4010 of the RPT device 4000.

In one form of the present technology power supply 4210 provideselectrical power to the RPT device 4000 only. In another form of thepresent technology, power supply 4210 provides electrical power to bothRPT device 4000 and humidifier 5000. The power supply may alsooptionally provide power to any actuator, controller and/or sensors fora vent arrangement as described throughout this specification

4.4.2.2 Input Devices 4220

In one form of the present technology, a RPT device 4000 includes one ormore input devices 4220 in the form of buttons, switches or dials toallow a person to interact with the device. These may be implemented forentering settings for operation of the components of the RPT device suchas the vent arrangement. The buttons, switches or dials may be physicaldevices, or software devices accessible via a touch screen. The buttons,switches or dials may, in one form, be physically connected to theexternal housing 4010, or may, in another form, be in wirelesscommunication with a receiver that is in electrical connection to thecentral controller 4230.

In one form the input device 4220 may be constructed and arranged toallow a person to select a value and/or a menu option.

4.4.2.3 Central Controller 4230

In one form of the present technology, the central controller 4230 is adedicated electronic circuit configured to receive input signal(s) fromthe input device 4220, and to provide output signal(s) to the outputdevice 4290 and/or the therapy device controller 4240.

In one form, the central controller 4230 is an application-specificintegrated circuit. In another form, the central controller 4230comprises discrete electronic components.

In another form of the present technology, the central controller 4230is a processor suitable to control a RPT device 4000 such as an x86INTEL processor.

A processor of a central controller 4230 suitable to control a RPTdevice 4000 in accordance with another form of the present technologyincludes a processor based on ARM Cortex-M processor from ARM Holdings.For example, an STM32 series microcontroller from ST MICROELECTRONICSmay be used.

Another processor suitable to control a RPT device 4000 in accordancewith a further alternative form of the present technology includes amember selected from the family ARMS-based 32-bit RISC CPUs. Forexample, an STR9 series microcontroller from ST MICROELECTRONICS may beused.

In certain alternative forms of the present technology, a 16-bit RISCCPU may be used as the processor for the RPT device 4000. For example aprocessor from the MSP430 family of microcontrollers, manufactured byTEXAS INSTRUMENTS, may be used.

The processor is configured to receive input signal(s) from one or moretransducers 4270, and one or more input devices 4220.

The processor is configured to provide output signal(s) to one or moreof an output device 4290, a therapy device controller 4240, a datacommunication interface 4280 and humidifier controller 5250.

In some forms of the present technology, the processor of the centralcontroller 4230, or multiple such processors, is configured to implementthe one or more methodologies described herein such as the one or morealgorithms 4300 expressed as computer programs stored in anon-transitory computer readable storage medium, such as memory 4260. Insome cases, as previously discussed, such processor(s) may be integratedwith a RPT device 4000. However, in some forms of the present technologythe processor(s) may be implemented discretely from the flow generationcomponents of the RPT device 4000, such as for purpose of performing anyof the methodologies described herein without directly controllingdelivery of a respiratory treatment. For example, such a processor mayperform any of the methodologies described herein for purposes ofdetermining control settings for a ventilator or other respiratoryrelated events by analysis of stored data such as from any of thesensors described herein. Similarly, such a processor may perform any ofthe methodologies described herein for purposes controlling operation ofany vent arrangement described in this specification.

4.4.2.4 Clock 4232

Preferably RPT device 4000 includes a clock 4232 that is connected toprocessor.

4.4.2.5 Therapy Device Controller 4240

In one form of the present technology, therapy device controller 4240 isa pressure control module 4330 that forms part of the algorithms 4300executed by the processor of the central controller 4230.

In one form of the present technology, therapy device controller 4240 isa dedicated motor control integrated circuit. For example, in one form aMC33035 brushless DC motor controller, manufactured by ONSEMI is used.

4.4.2.6 Protection Circuits 4250

Preferably a RPT device 4000 in accordance with the present technologycomprises one or more protection circuits 4250.

One form of protection circuit 4250 in accordance with the presenttechnology is an electrical protection circuit.

One form of protection circuit 4250 in accordance with the presenttechnology is a temperature or pressure safety circuit.

4.4.2.7 Memory 4260

In accordance with one form of the present technology the RPT device4000 includes memory 4260, preferably non-volatile memory. In someforms, memory 4260 may include battery powered static RAM. In someforms, memory 4260 may include volatile RAM.

Preferably memory 4260 is located on PCBA 4202. Memory 4260 may be inthe form of EEPROM, or NAND flash.

Additionally or alternatively, RPT device 4000 includes removable formof memory 4260, for example a memory card made in accordance with theSecure Digital (SD) standard.

In one form of the present technology, the memory 4260 acts as anon-transitory computer readable storage medium on which is storedcomputer program instructions expressing the one or more methodologiesdescribed herein, such as the one or more algorithms 4300.

4.4.2.8 Transducers 4270

Transducers may be internal of the device, or external of the RPTdevice. External transducers may be located for example on or form partof the air delivery circuit, e.g. the patient interface. Externaltransducers may be in the form of non-contact sensors such as a Dopplerradar movement sensor that transmit or transfer data to the RPT device.

4.4.2.8.1 Flow

A flow transducer 4274 in accordance with the present technology may bebased on a differential pressure transducer, for example, an SDP600Series differential pressure transducer from SENSIRION. The differentialpressure transducer is in fluid communication with the pneumaticcircuit, with one of each of the pressure transducers connected torespective first and second points in a flow restricting element.

In use, a signal representing total flow Qt from the flow transducer4274 is received by the processor.

4.4.2.8.2 Pressure

A pressure transducer 4272 in accordance with the present technology islocated in fluid communication with the pneumatic circuit. An example ofa suitable pressure transducer is a sensor from the HONEYWELL ASDXseries. An alternative suitable pressure transducer is a sensor from theNPA Series from GENERAL ELECTRIC.

In use, a signal from the pressure transducer 4272, is received by thecentral controller processor. In one form, the signal from the pressuretransducer 4272 is filtered prior to being received by the centralcontroller 4230.

4.4.2.8.3 Motor Speed

In one form of the present technology a motor speed signal 4276 isgenerated. A motor speed signal 4276 is preferably provided by therapydevice controller 4240. Motor speed may, for example, be generated by aspeed sensor, such as a Hall effect sensor.

4.4.2.9 Data Communication Systems 4280

In one preferred form of the present technology, a data communicationinterface 4280 is provided, and is connected to central controllerprocessor. Data communication interface 4280 is preferably connectableto remote external communication network 4282. Data communicationinterface 4280 is preferably connectable to local external communicationnetwork 4284. Preferably remote external communication network 4282 isconnectable to remote external device 4286. Preferably local externalcommunication network 4284 is connectable to local external device 4288.

In one form, data communication interface 4280 is part of processor ofcentral controller 4230. In another form, data communication interface4280 is an integrated circuit that is separate from the centralcontroller processor.

In one form, remote external communication network 4282 is the Internet.The data communication interface 4280 may use wired communication (e.g.via Ethernet, or optical fibre) or a wireless protocol to connect to theInternet.

In one form, local external communication network 4284 utilises one ormore communication standards, such as Bluetooth, or a consumer infraredprotocol.

In one form, remote external device 4286 is one or more computers, forexample a cluster of networked computers. In one form, remote externaldevice 4286 may be virtual computers, rather than physical computers. Ineither case, such remote external device 4286 may be accessible to anappropriately authorised person such as a clinician.

Preferably local external device 4288 is a personal computer, mobilephone, tablet or remote control.

4.4.2.10 Output Devices Including Optional Display, Alarms

An output device 4290 in accordance with the present technology may takethe form of one or more of a visual, audio and haptic unit. A visualdisplay may be a Liquid Crystal Display (LCD) or Light Emitting Diode(LED) display.

4.4.2.10.1 Display Driver 4292

A display driver 4292 receives as an input the characters, symbols, orimages intended for display on the display 4294, and converts them tocommands that cause the display 4294 to display those characters,symbols, or images.

4.4.2.10.2 Display 4294

A display 4294 is configured to visually display characters, symbols, orimages in response to commands received from the display driver 4292.For example, the display 4294 may be an eight-segment display, in whichcase the display driver 4292 converts each character or symbol, such asthe figure “0”, to eight logical signals indicating whether the eightrespective segments are to be activated to display a particularcharacter or symbol.

4.5 COMMUNICATION AND DATA MANAGEMENT SYSTEM

FIG. 7 depicts an example system 700 in which aspects of the disclosuremay be implemented. This example should not be considered as limitingthe scope of the disclosure or usefulness of the features describedherein. In this example, system 700 includes server 710, patient devices720, 730, and 740, storage systems 750, as well as computing device 760.These devices may each communicate over network 4282. System 700 may bescaled to any size network. For example, while only three patientdevices 720, 730, and 740 are shown, system 700 may include any numberof patient devices.

Each patient device 720, 730, and 740 may include one or more devices,including RPT 4000, humidifier 5000, and patient interface 3000. Inaddition, each patient device 720, 730, and 740 may be operated atremote locations and by different patients. While only controller 4230and memory 4260 are shown in patient device 720, each patient device mayinclude any of the components discussed above in connection with RPT4000, humidifier 5000, and patient interface 3000. In addition, whilepatient devices 720, 730, and 740 are shown as communicating directlywith the server 710 or the computing device 760 over 4282, each patientdevice may also communicate over network 4282 via an external computingdevice (not shown). For example, patient device 720 may communicate witha personal computer that transmits data over network 4282.

Servers 710 may contain one or more processors 712, memory 714 and maybe incorporated with other components typically present in generalpurpose computing devices. Memory 714 of server 710 may storeinformation accessible by processor 712, including instructions 715 thatcan be executed by the processor 712. Memory 714 may also include data718 that can be retrieved, manipulated or stored by processor 712. Thememory can be of any non-transitory type capable of storing informationaccessible by the processor. The instructions 716 may includeinstructions that are directly or indirectly executed by processor 712.In that regard, the terms “instructions,” “application,” “steps” and“programs” can be used interchangeably herein. Functions, methods androutines of the instructions are explained in more detail below.

Data 718 may be retrieved, stored or modified by processor 712 inaccordance with the instructions 716. For instance, although the subjectmatter described herein is not limited by any particular data structure,the data can be stored in computer registers, in a relational databaseas a table having many different fields and records, or XML documents.Data 718 may also be any information sufficient to identify or calculaterelevant information, such as numbers, descriptive text, proprietarycodes, pointers, references to data stored in other memories such as atother network locations. The one or more processors 712 may includeconventional processors, such as a CPU, or may be a hardware-basedcomponent, such as an ASIC.

Although FIG. 7 functionally illustrates the processor, memory, andother elements of server 710, computing device 760 and patient devices720, 730, and 740 as each being within one block, the various componentsof each device may be stored within the different physical housings. Forexample, memory 714 may be a hard drive or other storage media locatedin a housing different from that of server 710. Similarly, processor 712may include a plurality of processors, some or all of which are locatedin a housing different from that of server 710. Accordingly, referencesto a processor, computer, computing device, or memory will be understoodto include references to a collection of processors, computers,computing devices, or memories that may or may not operate in parallel.Although some functions are described herein as taking place on a singlecomputing device having a single processor, various aspects of thedisclosure may be implemented by a plurality of computing devicescommunicating information with one another, such as by communicatingover network 4282.

In many instances, it is preferable for patient devices 720, 730, and740 to communicate with network 4282 using wireless communication.However, network 4282 and intervening nodes described herein can beinterconnected using various protocols and systems, such that thenetwork can be part of the Internet, World Wide Web, specific intranets,wide area networks, local networks, or cell phone networks. The networkcan utilize standard communications protocols, such as Ethernet, Wi-Fiand HTTP, protocols that are proprietary to one or more companies, andvarious combinations of the foregoing. Although certain advantages areobtained when information is transmitted or received as noted above,other aspects of the subject matter described herein are not limited toany particular manner of transmission of information.

Servers 710 may include one or more communication servers that arecapable of communicating with storage system 750, computing device 760,and patient devices 720, 730, and 740 via network 4282. As will bedescribed in greater detail below, servers 710 may transmit updates 716of software and firmware over network 4282 to patient devices 720, 730,and 740. In turn, patient devices 720, 730, and 740 may transmit data toserver 710 in accordance with software and firmware in the form of theinstruction sets 726.

The computing device 760 may be configured similarly to the server 710,with one or more processors 762, memory 764 and instructions asdescribed above. Each such computing device may be a personal computingdevice intended for use by a clinician and have all of the componentsnormally used in connection with a personal computing device such as acentral processing unit (CPU), memory (e.g., RAM and internal harddrives) storing data and instructions, a display such as a display 766(e.g., a monitor having a screen, a touch-screen, a projector, atelevision, or other device that is operable to display information),and user input device 768 (e.g., a mouse, keyboard, touch-screen ormicrophone).

4.6 EXAMPLE METHODS

As discussed above, each patient device 720, 730, and 740 shown in FIG.7 may include one or more medical devices, including RPT 4000,humidifier 5000, and patient interface 3000. In performing theoperations described above, patient devices 720, 730, and 740 mayimplement instruction sets 726, which may include software or firmware.As discussed above in connection with FIG. 4c , RPT 4000 may includemultiple controllers, such as humidifier controller 5250 and therapydevice controller 4240. Each of these controllers may operate inconnection with a specific instruction set 726. Accordingly, eachinstruction set may relate to a specific component of the patientdevice, including the components discussed above. For example, returningto FIG. 7, patient device 720 is shown as including a number of modules,including communications module 721, humidifier module 723, and alarmmodule 725. Each of these modules may access and implement a distinctinstruction set 726. In another example, a particular instruction set726 may be implemented by more than one module, including any of themodules discussed above.

As patient devices 720, 730, 740 are used by their respective patients,updates to instruction sets 726 may become available and necessary. Suchupdates may be associated with improving specific functions or fixingidentified problems with operational aspects of one or more modules ofthe device. Thus, in some instances an update may be essential for theefficient administration of the patient treatment and even for thesafety of the patient. In accordance with one aspect of the disclosure,one or more instruction sets 726 may be automatically updated overcommunication network 4282. In particular, servers 710 may transmit oneor more instruction set updates 716 to one or more of the patientdevices 720, 730, and 740. Upon receiving an instruction set update 716,each patient device 720, 730, and 740 may alter instruction sets 726 ina manner indicated by the transmitted instruction set update 716. Inthis way, patient device may be easily upgraded and otherwise customizedremotely, without requiring a patient to bring the patient device to aclinician or to a service center.

In one aspect, specific patient devices may be selected as being able toreceive, or otherwise suitable to receive, a particular update. Forexample, server 710 may determine that patient device 720 should receivea particular instruction set update 716, while patient devices 730 and740 should not. In order to identify the specific patient device thatwill receive a particular update, server 710 may maintain configurationdata 718 for each patient device 720, 730, and 740. Configuration data718 may include any information that may be used to identify aparticular patient device, including a serial number, identification ofthe software and firmware versions that are currently being implementedby the patient device, and hardware version numbers. Configuration data718 may also include a record of the instruction set updates that havepreviously been transmitted to a patient device and an indication ofwhether each transmitted instruction set update was successfully orunsuccessfully applied to patient device. In addition, configurationdata 718 is not limited to information that is distinct with respect toone particular patient device but may include information that isapplicable to a number of patient devices. For example, configurationdata 718 may include identification of the patient device's supplier orretailer, as well as the location or region in which the patient deviceis being used. Alternatively, an update may be triggered by otherfactors, such as a fault condition that can be fixed by a specificupdate.

Configuration data 718 may be provided by the patient devices 720, 730,and 740 through a registration process. For example, patient device 720may transmit configuration data 728 over network 4282 to server 710.Server 710 may then store the received configuration data 728 in memory714 as configuration data 718. Registration of a patient device'sconfiguration data 718 may occur upon the patient's initial use of thepatient device. In addition, configuration data 718 may be updated onserver 710 upon any change that occurs in the configuration data 728.For example, patient device 720 may transmit a notification to server710 that it has successfully updated the firmware for its humidifiermodule 723 from a first version to a second version. Server 710 may thenupdate configuration data 718 so as to indicate that patient device 720is currently implementing the second version of the humidifier modulefirmware. In one example, patient device 720 may check its currentconfiguration data 728 each time it is started and report any changes inconfiguration data 728 to server 710.

In accordance with one aspect, a user of computing device 760 may selectparticular patient devices to update by communicating with server 710.For example, a user of computing device 760 may access a website thatprovides an interface with server 710 by which computing device 760 maydesignate a particular update 716 for particular patient devices 720,730 and 740. In order to identify the patient devices for which anupdate should be performed, computing device 760 may search memory 714of server 710 for patient devices that meet certain criteria. Forexample, a user of computing device 760 may request that server 710identify all patient devices that are implementing a specific softwareversion or have a serial number within a particular range. In anotherexample, computing device 760 may request a list of all patient devicesthat have been purchased from a particular retailer.

The user of the computing device 760 may identify, via server 710, thepatient devices that are to be updated. If there are more than onepossible updates, the user may also have to identify or select thespecific update 716 to be provided to the patient devices. Inidentifying a particular update, the user may identify which componentsof the patient devices are to be updated, as well as the particularversion of the software or firmware that is to be implemented by thecomponent. For example, the user of computing device 760 may requestthat server 710 provide patient devices 720 and 730 with an update 716for humidifier module 723 and that the update be for version 3.1 ofhumidifier firmware. Server 710 may then transmit the selected update716 to patient devices 720 and 730. Version 3.1 of the firmware mayinclude new or different settings than the settings being currentlyimplemented by patient devices 720 and 730. These new settings may beimplemented once patient devices 720 and 730 have installed version 3.1of the firmware. While the process of selecting an update 716 andtransmitting the selected update 716 may be performed by a single server710, it may alternatively be performed by more than one server 710. Forexample, computing device 760 may make an update request with acommunications server. The communications server may then transmit therequest to a download server that, in turn, transmits the selectedupdate to the designated patient devices.

The instruction update data may also include any one of the following;data specifying where to get the instruction update from, e.g. hostserver, port, filename; the schedule time for performing the update foreach device so that large volumes of device updates can be effectivelymanaged; whether or not to request the patient to confirm that theupdate should be applied; instructions for the update not be applieduntil patient treatment is stopped, if applicable; data structure andfunctionality enabling cancelling upgrades that have not yet occurred,if necessary; a batch capability to request bulk upgrades in a singleoperation as well as the ability to check the status of these upgradesafterwards in a single operation indicating which upgrades in the listsucceeded, which failed, which have not started etc.

In providing updates 716 to patient devices 720, 730 and 740, server 710may also transmit verification data that can be used to verify that theupdate has been downloaded successfully. Each update 716 may includeverification data. The verification data may take the form of achecksum, a cyclic redundancy check, or identification of the size ofthe update file. For example, server 710 may transmit to patient device720 an update 716 that includes a checksum. Patient device 720 maycompare the checksum against the received update 716 to determine if theentire update has been received. If the downloaded update matches thechecksum, patient device may install the update and transmit anindication to server 710 that installation was successful. However, ifthe downloaded update does not match the checksum, patient device maynot install the update and may transmit an indication to server 710 thatinstallation did not occur.

A transmission from server 710 to patient device 720 may include anupdate for more than one component. For example, a particular update 716may be transmitted from server 710 to patient device 720 that modifiesmultiple instruction sets 726 for multiple components, such asinstruction sets 726 for communications module 721 and humidifier module723. In another example, a particular instruction set 726 may beimplemented by multiple components, so that a modification of thatinstruction set 726 causes a modification of those multiple components.Multiple updates may also be transmitted and applied to a single patientdevice 720. If multiple updates 716 are included in a transmission,server 710 may identify the order in which the updates are to occur. Thepatient device in receipt of the transmission may then implement theupdates 716 in accordance with the order designated by server 710. Asingle component of the patient device may need to be updated more thanonce, in order for the final version of the instruction set to beimplemented. For example, patient device 720 may need to download andinstall version 2.0 of an instruction set before version 3.0 may beinstalled. Accordingly, configuration data 718 may includeidentification of patient devices 720, 730 and 740 that are currentlycapable of installing a particular update 716, as well as identificationof other updates that must be installed in order for the particularupdate 716 to be installed. In another example, a transmitted update 716may include an identification of the version or versions of instructionsets 726 that are needed in order for update 716 to be installed. Priorto installing update 716, patient device 720 may compare the requiredversions identified in update 716 with the version that it is currentlyimplementing. Patient device 720 may avoid installing update 716 ifpatient device 720 is not currently implementing one of the requiredversions.

Patient device 720 may determine whether it satisfies a specified buildstandard identified by update 716, and perform or avoid installation ofupdate 716 based on the determination. For example, the identified buildstandard may include the combination of components that are needed forthe update to be installed. Patient device 720 may determine whether itmeets the identified build standard, such as by determining if it isusing the identified combination of components. If the identifiedcomponents are being used by patient device 720, those components may beupdated in accordance with update 716. However, patient device 720 mayavoid installing update 716 if patient device 720 does not contain oneor more of the identified components. In one example, patient device 720may avoid installing only the portions of update 716 that relate to thecomponents that patient device 720 does not contain or use, but proceedwith installing other portions of update 716.

In accordance with one aspect, the patient devices may be updated inaccordance with a schedule. For example, a user of computing device 760may provide server 710 with a schedule of updates, such as byidentifying the dates on which particular patient devices are to receiveparticular updates 716. Server 710 may then transmit updates 716 inaccordance with the schedule. In one example, the schedule may beincorporated into the configuration data 718 for each patient device. Inthis way, an update that applies to a large number of patient devicesmay be applied over an extended period of time, such as over a period ofweeks or months, in order to decrease the load that network 4282 musttransmit at any given time. When a patient device is scheduled toreceive an update 716, server 710 may transmit an update request. Theupdate request may take the form of an SMS message or some othershoulder tap transmission. Upon receiving the update request from server710, patient device 720 may respond with an indication that it isprepared to receive the update. The update may then be transmitted toand installed by patient device 720. Server 710 may also cancel updates716 that are scheduled to occur. For example, a user of computing device760 may send a request that a particular update 716 be cancelled for oneor more patient devices 720, 730, and 740. In response to the request ofcomputing device 760, server 710 may remove the particular update 716from a list of scheduled updates. If the update has already beentransmitted to one or more of the patient devices, but not yetinstalled, server 710 may transmit au update cancellation to the one ormore patient devices. Upon receiving the update cancellation, patientdevices 720, 730, and 740 may delete the received update 716 from memorybefore it is installed.

Alternatively, the transmission may occur on a specific suitable day,but the respective device may be instructed to implement the update on aspecific later date. After receiving an update from server 710, patientdevice 720 may wait before installing the update for various reasons.For example, if a patient is receiving treatment from patient device 720when the update is received, patient device 720 may wait until thepatient's treatment has ended before installing the update. This mayprevent a patient's therapy from being interrupted or otherwisenegatively affected by the installation of the update. In one aspect,the update may indicate whether it may be installed while the patientdevice is being used. In particular, the update may indicate specificoperations that may be performed by the patient device while the updateis being performed. For example, update 716 may relate solely tocommunications module 721, which does not relate to operations that areperformed while the patient device provides respiratory therapy.Accordingly, update 716 may indicate that it may be installed whilepatient device 720 is being used to provide respiratory therapy. Duringinstallation, patient device 720 may display a notice indicating thatpatient device 720 is being updated. The notice may include displaying amessage stating that the patient should not turn off the patient deviceand that the patient should wait until the update has been completedbefore using the patient device in particular manners. In one example,patient device 720 may require confirmation from the patient before anupdate is installed. Also, new software may be downloaded by manydevices over a period of time, however the downloaded update can beinstalled on all devices at the same day for marketing or communicationpurposes.

In accordance with one aspect, a user of computing device 760 may queryserver 710 for the status of updates 716. For example, computing device760 may request identification of those patient devices that have notreceived or have not yet installed a particular update 716. In addition,computing device 760 may request a list of all patient devices for whichone or more updates 716 have been installed, as well as informationregarding any errors that have occurred in connection with thetransmission and installation of updates 716. In addition, server 710may provide computing device 760 with a list of current instructionsets, such as versions of software and firmware, that particular patientdevices are currently implementing. For example, computing device 760may query server 710 for a list of instruction sets 726 beingimplemented by patient device 720. Sever 710 may access configurationdata 718 in order to identify the queried information and transmit theinformation to computing device 760. Computing device 760 may make thequery and receive the queried information from server 710 by accessing awebsite or some other server interface. Server 710 may require thatcomputing device 760 provide identification information or a password inconnection with the query, so as to maintain the confidentiality ofpatient information.

FIG. 8 shows a flow diagram 800 that may be performed by a patientdevice, such as patient device 720 of system 700. As described above, apatient device may store and implement sets of instructions. In block802, the patient device may implement a set of instructions, such assoftware or firmware that is currently accessible to the patient device.The set of instructions may relate to the operation of a plurality ofcomponents within the patient device and need not be stored at a singlelocation. In implementing the set of instructions, the patient devicemay transmit data over a network to one or more external devices (Block804). For example, patient device 720 may transmit, over network 4282,data relating to a patient's use of patient device 720 in accordancewith one or more sets of instructions. This transmission may includeinformation about the dates and times for which the patient has used thepatient device. The patient device may also receive transmissions fromexternal devices, such as server 710, and may determine whether thereceived transmission is related to an update to one or more instructionsets. (Block 806). For example, the patient device may receive atransmission indicating that update data may be accessed at a particularlocation, such as at a particular address of a server. If no update hasbeen received, the patient device may continue to implement the currentinstruction set (Block 802). If an indication of an update is received,the patient device may receive the update data, such as by requesting oraccessing update files at an identified address.

The patient device may determine if there is an error in relation to theupdate data (Block 808). For example, as described above, patient devicemay compare the update with a checksum to determine that the entireupdate has been received. In addition, patient device may determinewhether the version of the instruction set that it is currentlyimplemented matches one of the versions that are needed in order for theupdate to be installed. If it is determined that an error exists inrelation to the update, the patient device may transmit an errornotification (Block 810). For example, patient device 720 may transmit anotification to server 710 indicating that the update did not match thechecksum that was provided. The notification may also include a requestfor the update to be retransmitted.

If no error is detected in relation to the update, the patient devicemay install the update (Block 812). As described above, the update mayinclude modifying one or more sets of instructions. The modification mayinclude deleting a portion of an instruction set and adding to theinstruction set, as well as replacing an original instruction set withan entirely new instruction set. As set forth above, an update mayinclude modifications to various instruction sets, including instructionsets for different components of the patient device. Upon installing theupdate, the patient device may perform a check to determine if theinstallation was successful, including performing a check of eachupdated component (Block 814). If the installation was not successful,the patient device may transmit an error notification (Block 810). Inaddition the patient device may revert back to and implement theoriginal instruction set in accordance with Block 802. If installationis determined to be successful, the patient device may transmit anotification to an external device, such as server 710, indicating thatthe update has been installed (Block 816). The patient device may alsoaccess and implement the current instruction sets, including the updatedinstruction sets, in accordance with Block 802.

FIG. 9 shows flow diagram 900 that may be performed by computing devicesof the disclosed system, including server 710 of system 700. In Block902, a server may receive a query for identification of patient devicesthat meet one or more criteria. For example, as described above, server710 may receive a query from computing device 760. This query may seekidentification of all patient devices that meet one or more criteriaprovided by a user of computing device 760. The criteria may be based onany number of aspects or features of the patient device, such the regionin which the patient device is located, the patient device's serialnumbers, as well as software and firmware versions that are currentlybeing implemented by the patient device. The server may accessconfiguration data in response to the received query (Block 904), andmay respond to the query by transmitting data that identifies thepatient devices for which the identified criteria are met (Block 906).

The server may then receive a request for one or more updates to betransmitted to one or more patient devices (Block 908). For example, asdescribed above, computing device 760 may receive a list from server 710of patient devices 720, 730 and 740 that meet criteria provided by theuser of computing device 760. The user may then select specific updates716 to be transmitted to patient devices 720, 730, and 740. Uponreceiving the request of Block 908, the server may access update data(Block 910) and transmit the update data to the patient devicesidentified in the received request (Block 912). The functions in items902-908 may be implemented in a different order. For example, the servermay receive the request for identifying devices with specificconfigurations at the same time (or even before) it receives the updaterequest and send the updates only to the devices that fulfil thespecified criteria. In addition, Block 910 need not be performed inorder for the update data to be transmitted to the patient device inaccordance with Block 912. For example, server 710 may transmit updatedata as an address that indicates the location of where the update filesare stored. The location identified by the address may be on server 710or elsewhere. In this way, the address for update files may be providedto the patient device without requiring server 710 to access the actualupdate file data that is stored at the identified location.

The server may also determine if the transmission and/or installation ofthe update was successful (Block 914). For example, the server mayreceive from each patient device either an error notification or amessage that the update was successfully installed. If an error occurredin the transmission of the update, the server may transmit the updatedata again for each patient device for which the error occurred (Block912). Alternatively, the actual update file (new software) can berequested by the treatment device itself from the file server, ratherthan being pushed by server 710 down to the device. The update of apatient device may not occur immediately, in that the update may becontingent on the occurence of one or more conditions. For example, theupdate data may indicate that the patient device is to install theupdate after the device has provided treatment for a period of 200hours. Accordingly, a substantial amount of time may lapse between Block912 and Block 914. However, if the transmission and installation aresuccessful, the server may revise the stored configuration data toindicate that the one or more patient devices are currently implementinginstruction sets that correspond to the transmitted updates (Block 916)and report that the update was successful (Block 918). For example, ifthe one or more of the patient devices have been successfully updated,server 710 may transmit a message to computing device 760 to notify auser, such as technical personnel, that the update is complete. Thismessage may identify the specific patient devices, or group of patientdevices, that have successfully installed the update.

While the operations set forth in FIGS. 8 and 9 may each be performed bya single device, the operations may alternatively be performed by morethan one device. For example, a patient device may communicate with apersonal computer over a wireless network, so that the personal computermay perform one or more of the operations described above. The serverreferenced in connection with FIGS. 8 and 9 may also include a pluralityof servers. Regarding the specific operations shown in FIGS. 8 and 9,various operations may be added or removed from flow diagrams 800 and900. In addition, various operations need not be performed in the sameorder as set forth in flow diagrams 800 and 900. For example, the servermay transmit update information to the treatment devices indicating whatupdate is required, where to obtain it (host, port, filename) and how toverify it (e.g. checksum/CRC). The treatment device comms module maythen requests the update file (instructions) from the specified host(server). This slightly different functional diagram allows distributingthe load of downloading large volumes of software over many servers ifnecessary i.e. not just from Server 710, as shown in the FIG. 7. Inaddition, the treatment device can re-request the update file (i.e. thenew software) from the specified server itself if there is atransmission error without interaction with server 710. It is alsopossible that the server, upon being notified of an error, could re-trythe operation as described above.

4.7 GLOSSARY

In certain forms of the present technology, one or more of the followingdefinitions may apply. In other forms of the present technology,alternative definitions may apply.

4.7.1 General

Air: Air will be taken to include breathable gases, for example air withsupplemental oxygen.

Continuous Positive Airway Pressure (CPAP): CPAP treatment will be takento mean the application of a supply of air or breathable gas to theentrance to the airways at a pressure that is continuously positive withrespect to atmosphere, and preferably approximately constant through arespiratory cycle of a patient. In some forms, the pressure at theentrance to the airways will vary by a few centimeters of water within asingle respiratory cycle, for example being higher during inhalation andlower during exhalation. In some forms, the pressure at the entrance tothe airways will be slightly higher during exhalation, and slightlylower during inhalation. In some forms, the pressure will vary betweendifferent respiratory cycles of the patient, for example being increasedin response to detection of indications of partial upper airwayobstruction, and decreased in the absence of indications of partialupper airway obstruction.

4.7.2 Materials

Silicone or Silicone Elastomer: A synthetic rubber. In thisspecification, a reference to silicone is a reference to liquid siliconerubber (LSR) or a compression moulded silicone rubber (CMSR). One formof commercially available LSR is SILASTIC (included in the range ofproducts sold under this trademark), manufactured by Dow Corning.Another manufacturer of LSR is Wacker. Unless otherwise specified to thecontrary, a preferred form of LSR has a Shore A (or Type A) indentationhardness in the range of about 35 to about 45 as measured using ASTMD2240.

Polycarbonate: a typically transparent thermoplastic polymer ofBisphenol-A Carbonate.

4.7.3 Aspects of a Patient Interface

Anti-asphyxia valve (AAV): The component or sub-assembly of a masksystem that, by opening to atmosphere in a failsafe manner, reduces therisk of excessive CO₂ rebreathing by a patient.

Elbow: A conduit that directs an axis of flow of air to change directionthrough an angle. In one form, the angle may be approximately 90degrees. In another form, the angle may be less than 90 degrees. Theconduit may have an approximately circular cross-section. In anotherform the conduit may have an oval or rectangular cross-section.

Frame: Frame will be taken to mean a mask structure that bears the loadof tension between two or more points of connection with a headgear. Amask frame may be a non-airtight load bearing structure in the mask.However, some forms of mask frame may also be air-tight.

Headgear: Headgear will be taken to mean a form of positioning andstabilizing structure designed for use on a head. Preferably theheadgear comprises a collection of one or more struts, ties andstiffeners configured to locate and retain a patient interface inposition on a patient's face for delivery of respiratory therapy. Someties are formed of a soft, flexible, elastic material such as alaminated composite of foam and fabric.

Membrane: Membrane will be taken to mean a typically thin element thathas, preferably, substantially no resistance to bending, but hasresistance to being stretched.

Plenum chamber: a patient interface plenum chamber will be taken to meana portion of a patient interface having walls enclosing a volume ofspace, such as for a full-face mask (e.g., nose and mouth mask), a nasalmask or a nasal pillow, the volume having air therein pressurised aboveatmospheric pressure in use by the patient. A shell may form part of thewalls of a patient interface plenum chamber. In one form, a region ofthe patient's face abuts one of the walls of the plenum chamber, such asvia a cushion or seal.

Seal: The noun form (“a seal”) will be taken to mean a structure orbarrier that intentionally resists the flow of air through the interfaceof two surfaces. The verb form (“to seal”) will be taken to mean toresist a flow of air.

Shell: A shell will preferably be taken to mean a curved structurehaving bending, tensile and compressive stiffness, for example, aportion of a mask that forms a curved structural wall of the mask.Preferably, compared to its overall dimensions it is relatively thin. Insome forms, a shell may be faceted. Preferably such walls are airtight,although in some forms they may not be airtight.

Stiffener: A stiffener will be taken to mean a structural componentdesigned to increase the bending resistance of another component in atleast one direction.

Strut: A strut will be taken to be a structural component designed toincrease the compression resistance of another component in at least onedirection.

Swivel: (noun) A subassembly of components configured to rotate about acommon axis, preferably independently, preferably under low torque. Inone form, the swivel may be constructed to rotate through an angle of atleast 360 degrees. In another form, the swivel may be constructed torotate through an angle less than 360 degrees. When used in the contextof an air delivery conduit, the sub-assembly of components preferablycomprises a matched pair of cylindrical conduits. Preferably there islittle or no leak flow of air from the swivel in use.

Tie: A tie will be taken to be a structural component designed to resisttension.

Vent: (noun) the structure that allows a deliberate controlled rate leakof air from an interior of the mask, or conduit to ambient air, to allowwashout of exhaled carbon dioxide (CO₂) and supply of oxygen (O₂).

4.8 OTHER REMARKS

A portion of the disclosure of this patent document contains materialwhich is subject to copyright protection. The copyright owner has noobjection to the facsimile reproduction by anyone of the patent documentor the patent disclosure, as it appears in the Patent and TrademarkOffice patent file or records, but otherwise reserves all copyrightrights whatsoever.

Unless the context clearly dictates otherwise and where a range ofvalues is provided, it is understood that each intervening value, to thetenth of the unit of the lower limit, between the upper and lower limitof that range, and any other stated or intervening value in that statedrange is encompassed within the technology. The upper and lower limitsof these intervening ranges, which may be independently included in theintervening ranges, are also encompassed within the technology, subjectto any specifically excluded limit in the stated range. Where the statedrange includes one or both of the limits, ranges excluding either orboth of those included limits are also included in the technology.

Furthermore, where a value or values are stated herein as beingimplemented as part of the technology, it is understood that such valuesmay be approximated, unless otherwise stated, and such values may beutilized to any suitable significant digit to the extent that apractical technical implementation may permit or require it.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this technology belongs. Although any methods andmaterials similar or equivalent to those described herein can also beused in the practice or testing of the present technology, a limitednumber of the exemplary methods and materials are described herein.

When a particular material is identified as being preferably used toconstruct a component, obvious alternative materials with similarproperties may be used as a substitute. Furthermore, unless specified tothe contrary, any and all components herein described are understood tobe capable of being manufactured and, as such, may be manufacturedtogether or separately.

It must be noted that as used herein and in the appended claims, thesingular forms “a”, “an”, and “the” include their plural equivalents,unless the context clearly dictates otherwise.

All publications mentioned herein are incorporated by reference todisclose and describe the methods and/or materials which are the subjectof those publications. The publications discussed herein are providedsolely for their disclosure prior to the filing date of the presentapplication. Nothing herein is to be construed as an admission that thepresent technology is not entitled to antedate such publication byvirtue of prior invention. Further, the dates of publication providedmay be different from the actual publication dates, which may need to beindependently confirmed.

Moreover, in interpreting the disclosure, all terms should beinterpreted in the broadest reasonable manner consistent with thecontext. In particular, the terms “comprises” and “comprising” should beinterpreted as referring to elements, components, or steps in anon-exclusive manner, indicating that the referenced elements,components, or steps may be present, or utilized, or combined with otherelements, components, or steps that are not expressly referenced.

The subject headings used in the detailed description are included onlyfor the ease of reference of the reader and should not be used to limitthe subject matter found throughout the disclosure or the claims. Thesubject headings should not be used in construing the scope of theclaims or the claim limitations.

Although the technology herein has been described with reference toparticular embodiments, it is to be understood that these embodimentsare merely illustrative of the principles and applications of thetechnology. In some instances, the terminology and symbols may implyspecific details that are not required to practice the technology. Forexample, although the terms “first” and “second” may be used, unlessotherwise specified, they are not intended to indicate any order but maybe utilised to distinguish between distinct elements. Furthermore,although process steps in the methodologies may be described orillustrated in an order, such an ordering is not required. Those skilledin the art will recognize that such ordering may be modified and/oraspects thereof may be conducted concurrently or even synchronously.

It is therefore to be understood that numerous modifications may be madeto the illustrative embodiments and that other arrangements may bedevised without departing from the spirit and scope of the technology.

LIST OF REFERENCE NUMBERS

-   -   communications system 700    -   server 710    -   processor 712    -   memory 714    -   instructions 715    -   instruction set update 716    -   configuration data 718    -   patient device 720    -   communications module 721    -   humidifier module 723    -   alarm module 725    -   instruction set 726    -   configuration data 728    -   patient device 720    -   patient device 730    -   patient device 740    -   storage system 750    -   computing device 760    -   processor 762    -   memory 764    -   display 766    -   user input device 768    -   patient 1000    -   patient interface 3000    -   Seal-forming structure 3100    -   plenum chamber 3200    -   perimeter 3210    -   position and stabilising structure 3300    -   vent 3400    -   connection port 3600    -   RPT device 4000    -   external housing 4010    -   upper portion of external housing 4012    -   lower portion of external housing 4014    -   panel 4015    -   chassis 4016    -   handle 4018    -   pneumatic block 4020    -   pneumatic component 4100    -   air filter 4110    -   inlet air filter 4112    -   outlet air filter 4114    -   muffler 4120    -   inlet muffler 4122    -   outlet muffler 4124    -   pressure device 4140    -   blower 4142    -   motor 4144    -   brush less DC motor 4144    -   back valve 4160    -   air circuit 4170    -   supplemental oxygen 4180    -   electrical component 4200    -   board assembly PCBA 4202    -   power supply 4210    -   input device 4220    -   central controller 4230    -   clock 4232    -   therapy device controller 4240    -   protection circuit 4250    -   memory 4260    -   transducer 4270    -   pressure transducer 4272    -   flow sensor 4274    -   motor speed signal 4276    -   data communication system 4280    -   remote external communication network 4282    -   local external communication network 4284    -   remote external device 4286    -   local external device 4288    -   output device 4290    -   display driver 4292    -   display 4294    -   algorithm 4300    -   pressure control module 4330    -   humidifier 5000    -   humidifier controller 5250

1. A method for updating devices for providing medical treatmentcomprising: accessing, by one or more processors, configuration datarelating to a plurality of patient devices, wherein the plurality ofpatient devices each implement a set of instructions; identifying, bythe one or more processors, one or more patient devices, from theplurality of patient devices, having configuration data that meets oneor more criteria; transmitting, by the one or more processors, aninstruction update to the one or more patient devices over a network;and updating, by the one or more processors, the configuration data foreach of the one or more patient devices that installed the instructionupdate.
 2. The method of claim 1, further comprising selecting by theone or more processors, out of a plurality of instruction updates, aninstruction update to be transmitted to the one or more patient devices,based on the configuration data.
 3. The method of claim 1 or claim 2,wherein selecting the one or more criteria and the instruction update isbased on received one or more transmissions from a remote computingdevice.
 4. The method of any one of claims 1 to 3, wherein theinstruction update also includes at least one of the following; dataspecifying a location of an instruction update file; instructions as towhich component of the device should the update be applied to; scheduletime for performing the update for each device; instructions on whetheror not to request confirmation that the update should be applied;instructions for the update not be applied until patient treatment isstopped, if applicable; data structure and functionality enablingcancelling upgrades that have not yet occurred; batch capability torequest bulk upgrades in a single operation; and an ability to check astatus of these upgrades in a single operation indicating the status ofthe upgrades.
 5. The method of any one of claims 1-4, wherein theplurality of patient devices are respiratory pressure therapy devices.6. The method of any one of claims 1-5, wherein transmitting theinstruction update further comprises transmitting verification data,wherein the verification data is used by the patient device to verifythat the instruction update that was successfully downloaded.
 7. Themethod of any one of claims 1-6, further comprising receiving, by theone or more processors, an indication from each of the one or morepatient devices whether the instruction update has been installed. 8.The method of claim 7, further comprising retransmitting the instructionupdate to each patient device for which it is determined that theinstruction update was not successfully installed.
 9. The method of anyone of claims 1-8, wherein the instruction update comprises a firstportion and a second portion, and wherein a first component of thepatient device operates in accordance with the first portion of theinstruction update and a second component operates in accordance withthe second portion of the instruction update.
 10. The method of any oneof claims 7-9, wherein the indication from each of the one or morepatient devices indicates that the instruction set was successfullyinstalled and further comprising transmitting, by the one or moreprocessors, a message identifying successful installation of theinstruction update for the one or more patient devices.
 11. The methodof any one of claims 1-10, wherein the configuration data comprises atleast one of a) a serial number, b) a version of the set of instructionsthat is currently installed on the patient device, c) a hardwareversion, and d) a region in which the patient device is being used. 12.The method of any one of claims 1-11, wherein the instruction updateincludes a plurality of upgrades to be applied to a single patientdevice.
 13. The method of any one of claims 1-12, wherein theconfiguration data includes a record of instruction updates that havepreviously been successfully or unsuccessfully applied to a particularpatient device, from the plurality of patient devices.
 14. A method forupdating a device for providing medical treatment comprising: accessing,by one or more processors, a first set of instructions for operation ofa patient device; performing, by the one or more processors, a first setof operations in accordance with the first instruction set; receiving,by the one or more processors, update data from a remote computingdevice over a network; updating, by the one or more processors, thefirst set of instructions in accordance with the update data so as togenerate an updated set of instructions; transmitting, by the one ormore processors, confirmation to the remote computing device that anupdate of the first set of instructions has occurred; and performing, bythe one or more processors, a second set of operations in accordancewith the updated set of instructions.
 15. The method of claim 14,wherein the patient device comprises a respiratory pressure therapydevice.
 16. The method of claim 14 or claim 15, wherein receiving updatedata further comprises receiving verification data, and furthercomprising determining whether the update data that was successfullydownloaded, based on the verification data.
 17. The method of any one ofclaims 14-16 further comprising: if the update data that was received isdetermined to be incomplete, transmitting an error notification to theremote computing device; and receiving a second transmission of updatedata.
 18. The method of any one of claims 14-17, wherein the update datacomprises a first portion and a second portion, and wherein a firstcomponent of the patient device operates in accordance with the firstportion of the update data and a second component operates in accordancewith the second portion of the update data.
 19. The method of any one ofclaims 14-18, wherein the first set of instructions and the updated setof instructions comprise at least one of software and firmware.
 20. Themethod of any one of claims 14-19, wherein transmitting confirmationthat the update of the first set of instructions has occurred comprisestransmitting configuration data indicating versions of at least one ofsoftware and firmware currently installed on the patient device.
 21. Themethod of any one of claims 14-20, further comprising determiningwhether the patient device satisfies a build standard identified by theinstruction update, and wherein updating the first set of instructionsoccurs based on a determination that the patient device satisfies thebuild standard.
 22. A system for updating a device in providing medicaltreatment comprising one or more computing devices, the one or morecomputing devices being configured to access configuration data relatingto a plurality of patient devices, wherein the plurality of patientdevices each implement a set of instructions; identify one or morepatient devices, from the plurality of patient devices, havingconfiguration data that meets one or more criteria; transmit aninstruction update to the one or more patient devices; and update theconfiguration data for each of the one or more patient devices that hasinstalled the instruction update.
 23. The system of claim 222, whereinthe one or more computing devices are configured to select, from aplurality of updates, an instruction update to be provided to the one ormore patient devices, based on the configuration data.
 24. The system ofclaim 22 or claim 23, wherein the one or more computing devices arefurther configured to receive one or more transmissions from a remotecomputing device, wherein the one or more transmissions identifies theone or more criteria and the instruction update.
 25. The system of anyone of claims 22-24, wherein the plurality of patient devices arerespiratory pressure therapy devices.
 26. The system of any one ofclaims 22-25, wherein the instruction update also includes at least oneof the following; data specifying a location of an instruction updatefile; instructions as to which component of the device should the updatebe applied to; schedule time for performing the update for each device;instructions on whether or not to request confirmation that the updateshould be applied; instructions for the update not be applied untilpatient treatment is stopped, if applicable; data structure andfunctionality enabling cancelling upgrades that have not yet occurred;batch capability to request bulk upgrades in a single operation; and anability to check a status of these upgrades in a single operationindicating the status of the upgrades.
 27. The system of any one ofclaims 22-26, wherein transmitting the instruction update furthercomprises transmitting verification data for the one or more patientdevices to verify that the instruction update that was received iscomplete.
 28. The system of any one of claims 22-27, wherein theconfiguration data comprises at least one of a) a serial number, b) aversion of the set of instructions that is currently installed on thepatient device, c) a hardware version, and d) a region in which thepatient device is being used.
 29. The system of any one of claims 22-28,wherein the one or more computing devices are further configured toretransmit the instruction update to each patient device for which it isdetermined that the instruction update was not successfully installed.30. The system of any one of claims 22-29, wherein the one or morecomputing devices are further configured to: receive an indication fromeach of the one or more patient devices that the instruction update hasbeen installed; and transmit a message indicating successfulinstallation of the instruction update for the one or more patientdevices.
 31. The system of any one of claims 22-30, wherein theinstruction update includes a plurality of upgrades to be applied to asingle patient device.
 32. The system of any one of claims 22-31,wherein the configuration data includes a record of instruction updatesthat have previously been successfully or unsuccessfully applied to aparticular patient device, from the plurality of patient devices.